The following data is part of a premarket notification filed by Technical Products, Inc. with the FDA for Dow Corning Silastic Elastomer Q7-4750.
Device ID | K973166 |
510k Number | K973166 |
Device Name: | DOW CORNING SILASTIC ELASTOMER Q7-4750 |
Classification | Elastomer, Silicone Block |
Applicant | TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
Contact | Norbert D Thompson |
Correspondent | Norbert D Thompson TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
Product Code | MIB |
CFR Regulation Number | 874.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-25 |
Decision Date | 1997-11-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B051803F0 | K973166 | 000 |
B051515020 | K973166 | 000 |
B051515030 | K973166 | 000 |
B051515040 | K973166 | 000 |
B051515050 | K973166 | 000 |
B051515060 | K973166 | 000 |
B051515070 | K973166 | 000 |
B051801S0 | K973166 | 000 |
B051802M0 | K973166 | 000 |
B051515010 | K973166 | 000 |